ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02715622
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Accelovance
Information provided by (Responsible Party):
Intuitive Surgical

Brief Summary:

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.

The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.


Condition or disease Intervention/treatment
Hernia Incisional Hernia Hernia, Inguinal, Indirect Hernia, Inguinal, Direct Inguinal Hernia Procedure: Hernia repair

Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
Open Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure
Procedure: Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

Laparoscopic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure
Procedure: Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

Robotic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure
Procedure: Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice




Primary Outcome Measures :
  1. Number of complications observed intraoperatively through 30 days [ Time Frame: 30 days ]
    Number of intraoperative and short-term complications related to hernia repair.

  2. Number of patient reported complications post 30-days through 3 years post procedure [ Time Frame: 30 days post-procedure to 3 years post-procedure ]
    Number of long-term complications related to hernia repair directly reported by patients


Secondary Outcome Measures :
  1. Patient reported outcomes on Quality of Life through 1 year [ Time Frame: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life ]
    Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year.

  2. Incisional or Inguinal Hernia Recurrence through 3 years [ Time Frame: 30 days post-procedure through 3 years ]
    Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.

  3. Patient reported outcomes on post-procedure pain through 3 years [ Time Frame: 2-4 weeks post-procedure through 3 years post-procedure ]
    Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

At least 900 patients will be enrolled in this post-market study that is planned to be conducted for mainly 2 types of hernia repairs, Incisional hernia repair and inguinal hernia repair ( robotic-assisted, lap and open). Up to 2000 patients may be enrolled.

Approximately 450 patients who will undergo inguinal hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) and approximately 450 patients who will undergo incisional hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) will be enrolled in this study at up to thirty (30) study centers

Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. All patients undergoing either an open, laparoscopic or robotic-assisted
  3. Incisional or Inguinal Hernia repair procedure
  4. Non-Emergent Incisional or Inguinal Hernia Repair cases

Exclusion Criteria:

  1. Emergent Cases for both Incisional and Inguinal Hernia
  2. Incisional Hernia related to ostomy formation
  3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715622


Contacts
Contact: Sundeep Master sundeep.master@intusurg.com
Contact: Monica Shah monica.shah@intusurg.com

Locations
United States, California
Beverly Hills Hernia Center Recruiting
Beverly Hills, California, United States, 90210
Contact: Isabel Capati    310-358-5020    bel@beverlyhillsherniacenter.com   
Principal Investigator: Shirin Towfigh, MD         
Vanderbilt University Medical Center Recruiting
Nashville, California, United States, 37232
Contact: Joan Kaiser    615-343-5821    joan.l.kaiser@Vanderbilt.Edu   
Principal Investigator: Richard Pierce, MD         
Kaiser Foundation Research Institute Recruiting
Oakland, California, United States, 94612
Contact: Nancy Mendelssohn    650-450-3459    Nancy.D.Mendelssohn@kp.org   
Contact: Jia Wu, Ph.D.    415-833-3480    Jia.X.Wu@kp.org   
Principal Investigator: Elliott Brill, MD         
United States, Florida
Florida Hospital - Celebration Health Recruiting
Celebration, Florida, United States, 34747
Contact: Lorraine Hickson    407-303-4702    lorraine.hickson@flhosp.org   
Principal Investigator: Carlos Ortiz-Ortiz, M.D.         
Baptist Health South Florida Recruiting
South Miami, Florida, United States, 33143
Contact: Jacquie Mejias    786-467-2539    jacquiem@baptisthealth.net   
Principal Investigator: Anthony Gonzalez, MD         
United States, Illinois
Southern Illinois Healthcare Recruiting
Carbondale, Illinois, United States, 62901
Contact: Justin Walker    314-795-0783    justin.walker@sih.net   
Principal Investigator: Adrian Martin, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Karen Ohara, BS, MT    312-942-3717    Karen_Ohara@rush.edu   
Principal Investigator: Keith Millikan, MD         
Progressive Surgical Associates Recruiting
New Lenox, Illinois, United States, 60451
Contact: Katie Powers    815-717-8730    kpowers.psa@gmail.com   
Principal Investigator: Reza Gamagami, MD         
United States, Kentucky
Louisville Surgical Associates Recruiting
Louisville, Kentucky, United States, 40215
Contact: Kylie Farmer    312-942-6379    KylieFarmer@KentuckyOneHealth.org   
Principal Investigator: John Olsofka, MD         
United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Tina Martinez    225-765-6547    tina.martinez@fmolhs.org   
Principal Investigator: Karl LeBlanc, MD         
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Mackenzie Skellan       mskellan@mdmercy.com   
Principal Investigator: Thomas Swope         
United States, Michigan
Spectrum Health System Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Christa Rood    616-486-6079    Christa.Rood@spectrumhealth.org   
Principal Investigator: Amy Banks-Venegoni, MD         
United States, New York
The Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Kelsey Gibson       kelsey.gibson@mountsinai.org   
Principal Investigator: Brian Jacob, MD         
United States, North Carolina
New Hanover Regional Medical Center Recruiting
Wilmington, North Carolina, United States, 28403
Contact: Belinda Lissor    910-667-9281    Belinda.Lissor@seahec.net   
Principal Investigator: William Hope, MD         
United States, Oklahoma
Hillcrest Medical Center Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Delores Hale    918-574-0611    deloreshale@gmail.com   
Principal Investigator: Eugene Dickens, MD         
United States, Tennessee
University of Tennessee Recruiting
Memphis, Tennessee, United States, 38120
Contact: Jessica Roberts    901-866-8530    jessica.roberts@bmg.md   
Principal Investigator: Guy Voeller, MD         
Sponsors and Collaborators
Intuitive Surgical
Accelovance
Investigators
Study Chair: Karl LeBlanc, MD Surgeon Group of Baton Rouge

Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT02715622     History of Changes
Other Study ID Numbers: ISI-PHS-2016
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes